Data Integrity for Analytical Instruments connected to a LIMS via a Middleware

How can I handle analysis devices that are connected to a LIMS via a middleware? The first data (raw data) is generated internally, processed in the middleware and sent to the LIMS. However, the manufacturer does not allow access to the original data in the automated analyser.

In the question, raw data is basically equated with the generation of the first data. This is not recommended. In the GMP environment, the raw data should be defined by the pharmaceutical manufacturer. The type of data generated is important for defining it. Is static data or dynamic data available? If the data is static, the raw data can consist of cumulative primary data (first generated data). In the case of dynamic data, raw data can be the original data.

The following definitions are necessary for answering this question:

Original Data

Those data that represent the first capture of the data and are still stored in the first location (e.g., analog data).

Primary Data

Processed data leading to the result on the respective device. When these data are collected on the device of origin, they can also be considered as original data (eg, digital data calculated from an analog signal).

Raw Data

The data set (out of the total available data) necessary for the reconstruction and evaluation of the derived outcome data relevant to patient safety, study results and / or product quality. Based on the data life cycle (see Fig.). It can be seen that raw data can be defined by the evaluation.

 

Once the essential output data has been defined, the second step determines - on the basis of data processing -  which input data (e.g. individual values) and processing operations are required.

In addition to the definition of the data types, it is also important to determine whether all individual values are required as raw data in order to be able to reproduce the result. If traceability is no longer possible because the generated data is not present in the LIMS, this process is not "compliant". At best, validation can help here by demonstrating that all relevant (to be defined) data is transferred to the LIMS in order to check the plausibility (traceability) of the result.

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